Last year, the French based company PIP (Poly Implant Prothèse) had their implants banned because it was discovered that they were utilizing a non-medical grade silicone as the filler for their gel implants. In addition, the recent reported death of a French woman from the rare form of cancer ALCL, who had PIP breast implants has led to a tremendous amount of media concern about a company recognized by few American women. Inspections in France as early as 2001 had revealed numerous non-conformities surrounding the manufacture of PIP implants. In 2009, it was reported that there were high rupture rates with their implants in France, leading to allegations of implant shell problems. In 2010 distribution was suspended and the company filed for bankruptcy. continue reading
The French PIP Silicone Breast Implant
Separate the Facts from Fiction on the Rare Association between ALCL and Breast Implants
The FDA issued a press release today concerning an uncommon form of lymphoma (ALCL) that has been reported to occur extremely rarely in women with breast implants. Epidemiologists have been following these reports since 1989 and the FDA press release today issued a summary of these investigations for both patients with breast implants and their physicians:
Awake Breast Augmentation – What they’re not telling you
The media is once again spinning with stories about “Awake Breast Augmentation”. For better or worse, some surgeons in my opinion, are using the media and internet to increase their market share by pushing the limits on safety, while losing site of the long term results of breast augmentation.
There are at least two very important concerns with regard to “Awake Breast Augmentation.” The first issue is patient safety. The advertised procedures certainly sound like a bargain. One patient was quoted to have saved almost $3000. The savings most likely come from the nonattendance of a board certified Anesthesiologist, or procedures that are not performed in an accredited surgical facility. Breast augmentation is a surgical procedure. There are risks associated with bleeding, infection, and damage to surrounding structures. In addition, this procedure adds the risk of overdosage of local anesthetics, a very real potential risk if the surgery is performed while the patient is awake. continue reading
Don’t be Mislead by Cohesion Confusion
The more cohesive silicone gel is, the thicker and firmer it becomes. Silicone gel comes in a range of firmness, and the highly cohesive breast implants are believed to be just firm enough to resist forming creases and folds, yet soft enough to feel like a natural breast. Unfortunately, many surgeons are using the term cohesive to describe the “regular” round FDA approved silicone gel implants. To be precise, they are correct; all silicone gel is cohesive to some degree. But the term cohesive has always meant form stability, and when patients ask for cohesive gel, it is because they want an implant that possesses resilience and shape retention. The form stable highly cohesive gels, “Gummy Bears” that are presently available in the United States are always shaped devices, they are presently not available in the United States in a round “version”. The intended advantage to a shaped device is that it offers the surgeon more options in selecting an implant that can fit your individual body shape and size, as well as the quality of your breast tissue. Studies of the form stable highly cohesive gel implants have been ongoing in Europe and the United States since 1993. continue reading